TriangleNCT01832727 · OUTCOME
Kaplan-Meier Estimates for Progression-free Survival (PFS) as Assessed by Investigator During Phase 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1 up to 14.1 months
What was measured
Progression-free survival (PFS) was defined as number of months between start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurs first. Disease progression was determined using IMWG-URC per investigator. The duration of PFS was right-censored for participants who met 1 of the following conditions: * 1\) starting a new anticancer therapy before documentation of disease progression or death; * 2\) death or disease progression immediately after more than 1 consecutively missed disease assessment visit or; * 3\) alive without documentation of disease progression before the data cutoff date. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
Analysis population: Safety population
Groups in this outcome
Phase 2 300 mg 2/7 Schedule
The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
| Group | Source count |
|---|---|
| Phase 2 300 mg 2/7 Schedule | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 300 mg 2/7 Schedule | 12.2 | Not reported | 3.5 | NA | not enough events to calculate |
Complete source fields
- classes
- categories
- measurements
- comment
- not enough events to calculate
- group Id
- OG000
- lower Limit
- 3.5
- upper Limit
- NA
- value
- 12.2
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- Progression-free survival (PFS) was defined as number of months between start of treatment and first evidence of documented disease progression or death (due to any cause), whichever occurs first. Disease progression was determined using IMWG-URC per investigator. The duration of PFS was right-censored for participants who met 1 of the following conditions: * 1\) starting a new anticancer therapy before documentation of disease progression or death; * 2\) death or disease progression immediately after more than 1 consecutively missed disease assessment visit or; * 3\) alive without documentation of disease progression before the data cutoff date. 95% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- The Cohort Safety Review Committee (CSRC) determined this dose as the recommended phase 2 dose (RP2D). Oprozomib 300 mg once daily on Days 1, 2, 8, and 9 of a 14-day treatment cycle in combination with 20 mg dexamethasone once daily on Days 1, 2, 8, and 9 of a 14-day cycle. Treatment was administered in 14-day cycles until disease progression, unacceptable toxicity, or study treatment discontinuation for any reason.
- id
- OG000
- title
- Phase 2 300 mg 2/7 Schedule
- param Type
- MEDIAN
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Day 1 up to 14.1 months
- title
- Kaplan-Meier Estimates for Progression-free Survival (PFS) as Assessed by Investigator During Phase 2
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice